FAVERIN fluvoxamine maleate 100mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluvoxamine maleate, Quantity: 100 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: mannitol; maize starch; pregelatinised potato starch; sodium stearylfumarate; colloidal anhydrous silica; hypromellose; macrogol 6000; purified talc; titanium dioxide

Administration route:

Oral

Units in package:

10 tablets (sample), 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

* for the treatment of major depression. * for the treatment of Obsessive Compulsive Disorder (OCD) in children aged 8 years and older and adults.

Product summary:

Visual Identification: oval, biconvex, scored, white film-coated tablet one side inscribed with '313' on either side of the score line on one face and plain on the other face.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-05-27

Patient Information leaflet

FAVERIN- Consumer Medicine Information
Page 1 of 5
FAVERIN TABLETS
_fluvoxamine maleate _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
THIS LEAFLET ANSWERS SOME OF THE
COMMON QUESTIONS ABOUT
FAVERIN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
PLEASE READ THIS LEAFLET BEFORE YOU
START TAKING FAVERIN.
If you are helping someone else
take FAVERIN, please read this
leaflet before you give the first dose.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking FAVERIN against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING FAVERIN, ASK YOUR DOCTOR
OR PHARMACIST.
Your doctor and pharmacist have
more information.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT FAVERIN IS USED FOR
FAVERIN belongs to a family of
medicines known as selective
serotonin reuptake inhibitors (SSRIs).
It is used to treat depression in
adults and a condition known as
"Obsessive Compulsive Disorder"
(OCD) in adults and children eight
years of age or older. Both of these
conditions are thought to be caused
by a chemical imbalance in parts of
the brain. FAVERIN corrects this
chemical imbalance and may help
relieve the symptoms of depression
and OCD.
Depression is longer lasting and/or
more severe than the "low moods"
everyone has from time to time due
to the stress of everyday life.
Depression caused by a chemical
imbalance in the brain can affect your
whole body and can cause emotional
and physical symptoms such as
feeling low in spirit, loss of interest in
activities, being unable to enjoy life,
poor appetite or overeating, disturbed
sleep, often waking up early, loss of
sex drive, lack of energy and feeling
guilty for no reason.
People with OCD can have two types
of symptoms – obsessions and
compulsions. Obsessions are
unwanted repeated thoughts or
feelings, which are ongoing.
Compulsions are the need to repeat
actions over and over. The
symptoms of OCD can vary

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
FAVERIN (FLUVOXAMINE MALEATE) TABLETS
1
NAME OF THE MEDICINE
Fluvoxamine maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of FAVERIN contains 50 mg or 100mg of fluvoxamine maleate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FAVERIN (fluvoxamine maleate) 100 mg: Oval, biconvex, scored, white
film-coated tablet one
side inscribed with '313' on either side of the score line on one face
and plain on the other
face.
FAVERIN (fluvoxamine maleate) 50 mg: Round, biconvex white film coated
scored tablets
inscribed with “291” on either side of the score line and other
face plain.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
FAVERIN (fluvoxamine maleate) is indicated for the treatment of major
depression in adults.
FAVERIN (fluvoxamine maleate) is also indicated for the treatment of
Obsessive-Compulsive
Disorder (OCD) in both children aged 8 years and older, adolescents
and adults.
4.2
D
OSE AND METHOD OF ADMINISTRATION
D
EPRESSION
The recommended starting dose of fluvoxamine is 50mg per day for one
week, given as a single
dose in the evening. Doses should be gradually increased (by 50mg per
week) until an effective
dose is reached, with a maximum of 300mg per day. (The usually
effective dose is 100mg/day.)
2
Doses up to 150mg can be given as a single dose. It is recommended
that total daily doses of
greater than 150mg be given in 2 or 3 divided doses.
If no improvement is observed within 6 weeks of initiation of therapy,
treatment with
fluvoxamine should be reconsidered. It is important to ascertain that
an adequate therapeutic
dose has been maintained throughout this period.
In agreement with the consensus statement of the WHO, antidepressant
medication should be
continued for at least 6 months after recovery from a depressive
episode.
O
BSESSIVE
C
OMPULSIVE
D
ISORDER
Adults:
The recommended starting dose of fluvoxamine is 50mg per day for 3 to
4 days. The dosage
should be increased gradually (i.e. by 50mg every 4 to